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Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

This study is currently recruiting participants.
Verified October 2012 by Dubai Health Authority
Sponsor:
Information provided by (Responsible Party):
Sivakami A Pai, Dubai Health Authority
ClinicalTrials.gov Identifier:
NCT01707745
First received: September 22, 2012
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP).

Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.


Condition Intervention
Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.
 Procedure: Intravitreal Bevacizumab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Dubai Health Authority:

Primary Outcome Measures:
  • Regression Of ROP [ Time Frame: Minimum 6 months follow up after intravitreal Avastin ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence of ROP [ Time Frame: minimum 6 months of follow up. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Avastin
Bevacizumab(Avastin) 0.75mg in 0.03 ml
 Procedure: Intravitreal Bevacizumab
Other Name: Intravitreal Avastin

  Eligibility

Ages Eligible for Study:   32 Weeks to 42 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: stage 2+ or stage 3+ Retinopathy of prematurity in Zone I or Zone II.

Informed written consent by parents or guardian.

-

Exclusion Criteria:

Refusal to give consent Critically ill neonates.

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707745

Contacts
Contact: Sivakami A Pai, MS, DNB, Phd 00971504148256
Contact: M A Dekhain, FRCS, MRCOpth 0097142195000 ext 6272 maDekhain@dha.gov.ae

Locations
United Arab Emirates
Dubai Hospital Recruiting
Dubai, UAE, United Arab Emirates
Contact: Sivakami A Pai, MS, DNB, Phd     00971504148256        
Contact: Moza A Dekhain, MRCOpthal, FRCS     009712195000 ext 6272     maDekhain@dha.gov.ae    
Principal Investigator: Sivakami A Pai, MS, DNB, Phd            
Sub-Investigator: Afra M Lootah, MSc, FRCS            
Sponsors and Collaborators
Sivakami A Pai
  More Information

No publications provided

Responsible Party: Sivakami A Pai, Doctor, Dubai Health Authority
ClinicalTrials.gov Identifier: NCT01707745     History of Changes
Other Study ID Numbers: Avastin for threshold ROP.
Study First Received: September 22, 2012
Last Updated: October 15, 2012
Health Authority: United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bevacizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013